With contract revenue growth of nearly 40%, CDMO (contract development and manufacturing organization) AMRI is seeing its acquisitions of OsoBio, two Aptuit facilities and a UK aseptic facility pay off.
Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.
The founder of a phony pharma company which made $12m importing fake chemo drugs to the US has been banned for life by the US FDA from working with any pharma businesses.
India’s Emcure Pharmaceuticals has been banned from shipping any of the drugs manufactured at its Maharashtra-based facility to the US, according to an import alert from the US FDA.
Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.
Canada has asked importers to quarantine APIs made by India’s Polydrug Laboratories over concerns about its manufacturing plant in Ambarnath in Maharashtra.
Allergan is set to acquire Kythera Biopharmaceuticals for $2.1bn (€1.9bn) and add the recently approved injectable ‘double-chin’ drug Kybella to its facial aesthetics portfolio.
Naming drugs using active pharmaceutical ingredients (API) rather than their salts will cut down on medication and dosing errors according to the US Food and Drug Administration (FDA).
EMA guidance on process validation for drugmakers is the latest update in cGMP regulations to manage a pharma world shifting from chemical to biological processing, says NNE Pharmaplan.
Site audits by Brazilian pharma regulator ANVISA are “exactly the opposite” to the US FDA’s, says CMO Kemwell as it prepares to export to Brazil for Johnson & Johnson.
Recent US FDA approval of products containing the excipient HPC has driven demand, according to Nippon Soda (Nisso) which has expanded its production facility in Japan.
Persuading API manufacturers to seek prequalification is a challenge according to the WHO, which wants to raise awarness about the process and the positive impact it has on a suppliers' reputation.
‘Epoch making’ revisions to Japanese drug laws have provided a pathway for development of safer, more innovative drugs according to MHLW director, Haruo Akagawa.
The EDQM is revising its water for injection (WFI) monograph to accomodate cheaper and greener alternatives to distillation and has called on injectable drugmakers to contribute.
Thirteen Taiwanese drugmakers have been fined and ordered to recall products by regulators concerned the APIs they contain are food rather than pharma grade.
Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.
Speciality Compounding has been ordered to cease production by the US Courts after tests confirmed injectable drugs made at its facility in Texas were contaminated by bacteria.
The FDA has tested hundreds of creatively named bogus supplements and found they contain hidden APIs. Take in-Pharmatechnologist.com's quiz and tell us which name is your favourite.
For the second time this year, the FDA has issued a warning letter to API (active pharmaceutical ingredient) and intermediate manufacturer Novacyl and this time it’s for the company’s manufacturing site in Thailand.
Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.
Celltrion has emphasised the savings Remsima ((inflizimab) could offer at a conference in Spain as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK.
The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.
In a wide-ranging interview that included his take on competition from Google and R&D spending, Pfizer CEO Ian Read offered a number of clues as to where his company is headed.
Ongoing demand for large-scale APIs combined with high capacity utilization has driven Cambrex Corporation to allot up to $85m (€70m) for manufacturing expansion in 2015.
ScinoPharm was hurt by weak US demand for the weight loss pill Qsymia, higher raw material prices and costs associated with its still unapproved plant in China in 2014.
Lonza signed a flurry of biopharma-related deals and launched a number of drug industry services in the final quarter of 2014 as its efforts to focus on pharma intensified.
The US FDA has published an import alert for an Australian manufacturing site of Eli Lilly after the agency found that its Cialis pills were tainted with the active ingredient of another popular ED (erectile dysfunction) drug -- Pfizer’s Viagra.
Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.
Injectable-heavy drug pipelines and increased biotech funding are driving up US demand for sterile manufacturing, according to UK-based Symbiosis, which is looking to help fill the gap left by several high-profile exits from the space.
Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.
The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.
The World Health Organisation says its prequalification scheme gives free help to makers of selected APIs, drugs and vaccines who want to boost their standards and access international markets.
Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.
